| Dillard Nasal Balloon Catheter (K181546) | Intuit Medical Products, LLC | 2020-01-03 |
| MPowRx Snoring Solution (also known as Good Morning Snore Solution) (K193239) | Mpowrx Health and Wellness Products 2012, Inc. | 2020-01-03 |
| AlignRT Plus (K193431) | Vision Rt, Ltd. | 2020-01-03 |
| Straumann Ceramic Healing Abutments (K192893) | Institut Straumann AG | 2020-01-03 |
| Flex Body SPEEDER (K193140) | Quality Electrodynamics, LLC | 2020-01-03 |
| NeuroBlate System (K193375) | Monteris Medical, | 2020-01-03 |
| Conformity stem, cemented (K191056) | United Orthopedic Corporation | 2020-01-03 |
| Endotics (K190669) | Era Endoscopy S.R.L. | 2020-01-03 |
| Z5-BL (K190243) | Z-Systems AG | 2020-01-03 |
| PALLAS 308/311 Solid-State UV Laser System (K191501) | Laseroptek Co., Ltd. | 2020-01-03 |
| SureMAX Family of Cervical Spacers (K193359) | Additive Implants, Inc. | 2020-01-03 |
| PiccGuard (K191195) | Piccguard, LLC | 2020-01-03 |
| ASAHI PTCA Guide Wire ASAHI Gaia Next (K192599) | Asahi Intecc Co., Ltd. | 2020-01-02 |
| Optilume Basic Urological Balloon Dilation Catheter (K191061) | Urotronic, Inc. | 2020-01-02 |
| OptoWire III (K191907) | Opsens, Inc. | 2020-01-02 |
| Elos Accurate Customized Abutment (K192457) | Elos Medtech Pinol A/S | 2020-01-02 |
| TunneLoc Tibial Fixation Device (K193092) | Biomet, Inc. | 2020-01-02 |
| Sterile LeadConfirm (K191739) | Alpha Omega Engineering , Ltd. | 2020-01-02 |
| Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP (K192216) | Invacare Corporation | 2020-01-02 |
| Air Next (K183089) | Nuvoair AB | 2020-01-02 |
| Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (K193360) | Radmedix, LLC | 2020-01-02 |
| OC-Auto SENSOR io iFOB Test (K191147) | Eiken Chemical Co., Ltd. | 2020-01-02 |
| Ureteral Stent Systems, Biliary Drainage Catheters (K191446) | Boston Scientific Corporation | 2020-01-02 |